Trial · NCT00554216

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

NCT00554216, Phase 3, Completed, VIVUS LLC; results first posted 2012-09-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults. Trials, record NCT00554216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00554216

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
NCT number: NCT00554216
Status: Completed
Phases: Phase 3
Enrollment: 1,267 participants, actual
Lead sponsor: VIVUS LLC
Conditions: Obesity
Interventions: VI-0521, VI-0521, Placebo matched phentermine/topiramate
First posted: 2007-11-06
Last updated: 2012-09-10
Results first posted: 2012-09-06

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Weight Loss From Baseline to Week 56	baseline to 56 weeks
Primary	Percentage of Subjects With at Least 5% Weight Loss at Week 56	baseline to 56 weeks

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Weight Loss From Baseline to Week 56	baseline to 56 weeks	intent-to-treat last-observation-carried-forward (ITT-LOCF)	percent weight loss	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Subjects With at Least 5% Weight Loss at Week 56	baseline to 56 weeks	intent-to-treat last-observation-carried-forward (ITT-LOCF)	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Weight Loss From Baseline to Week 56	Placebo	1.55	Standard Error 0.395	percent weight loss
Percent Weight Loss From Baseline to Week 56	VI-0521 Low	5.10	Standard Error 0.538	percent weight loss
Percent Weight Loss From Baseline to Week 56	VI-0521 Top	10.92	Standard Error 0.392	percent weight loss
Percentage of Subjects With at Least 5% Weight Loss at Week 56	Placebo	17.3		percentage of participants
Percentage of Subjects With at Least 5% Weight Loss at Week 56	VI-0521 Low	44.9		percentage of participants
Percentage of Subjects With at Least 5% Weight Loss at Week 56	VI-0521 Top	66.7		percentage of participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	514
Overall Study	STARTED	VI-0521 Low	241
Overall Study	STARTED	VI-0521 Top	512
Overall Study	COMPLETED	Placebo	272
Overall Study	COMPLETED	VI-0521 Low	147
Overall Study	COMPLETED	VI-0521 Top	340
Overall Study	NOT COMPLETED	Placebo	242
Overall Study	NOT COMPLETED	VI-0521 Low	94
Overall Study	NOT COMPLETED	VI-0521 Top	172

Source ClinicalTrials.gov

Adverse events138

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	upper respiratory tract infection	Infections and infestations	Placebo	56	513
other	upper respiratory tract infection	Infections and infestations	VI-0521 Low	38	240
other	upper respiratory tract infection	Infections and infestations	VI-0521 Top	63	511
other	nasopharyngitis	Infections and infestations	Placebo	37	513
other	nasopharyngitis	Infections and infestations	VI-0521 Low	30	240
other	nasopharyngitis	Infections and infestations	VI-0521 Top	46	511
other	sinusitis	Infections and infestations	Placebo	28	513
other	sinusitis	Infections and infestations	VI-0521 Low	18	240
other	sinusitis	Infections and infestations	VI-0521 Top	37	511
other	influenza	Infections and infestations	Placebo	24	513

1 to 10 of 138Source ClinicalTrials.gov

See all 138 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	VI-0521 Low
Total, all-cause mortality	VI-0521 Top
Total, other adverse events	Placebo	374	513
Total, other adverse events	VI-0521 Low	192	240
Total, other adverse events	VI-0521 Top	432	511
Total, serious adverse events	Placebo	14	513
Total, serious adverse events	VI-0521 Low	6	240
Total, serious adverse events	VI-0521 Top	13	511

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28455281	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00554216

GET https://conductscience.org/api/trials/v1/NCT00554216/events?page=2

API reference For AI assistants